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Comparison of Epidemiology and Clinical Outcomes of Influenza A & B Cases in Manitoba, Canada

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by International Centre for Infectious Diseases, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
International Centre for Infectious Diseases, Canada
ClinicalTrials.gov Identifier:
NCT01683630
First received: August 31, 2012
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

This study compares, by influenza type, the overall and cause-specific incidence rates of physician encounters, hospitalization and death following the diagnosis of a laboratory-confirmed influenza. Multivariate models will be used to assess the effects of influenza type on clinical outcomes (e.g. hospitalization) while accounting for confounding by various characteristics.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of the Epidemiology and Clinical Outcomes of Laboratory-Confirmed Influenza A and Influenza B Cases in Manitoba, Canada

Resource links provided by NLM:


Further study details as provided by International Centre for Infectious Diseases, Canada:

Primary Outcome Measures:
  • Age-adjusted incidence rates of hospitalization and death occurring within 1 month of the diagnosis of influenza [ Time Frame: up to 21 years ] [ Designated as safety issue: No ]
    Data records of hospitalization and death occurring within 1 month of the diagnosis of influenza, overall and stratified by demographic and clinical characteristics


Secondary Outcome Measures:
  • Annual incidence rates of influenza A and B cases [ Time Frame: up to 21 years ] [ Designated as safety issue: No ]
    Age adjusted incidence rates of influenza A and B cases among the whole Manitoba population.

  • Annual incidence rates of influenza A and B cases among certain subsets of the population [ Time Frame: up to 21 years ] [ Designated as safety issue: No ]
    Age-adjusted (when appropriate) annual incidence rates of influenza A and B cases among certain subsets of the Manitoba population.

  • Visits to health care provider within 6 months of the diagnosis of influenza [ Time Frame: up to 21 years ] [ Designated as safety issue: No ]
    Age-adjusted rate of visits to health care providers within 6 months of the diagnosis of influenza, overall and stratified by demographic and clinical characteristics.


Estimated Enrollment: 1280
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Annual epidemics of influenza are an important public health problem globally and in Canada. Each year, 10-25% of the Canadian population become infected with influenza. Most of these infections are typically asymptomatic or associated with a mild self-limiting illness. However, influenza can cause severe illness leading to hospitalization and death, especially among the very young, the elderly and among those with underlying chronic conditions. It has been estimated that on average about 4,000 influenza-related deaths occur in Canada each year. In addition, the economic burden of influenza is significant because of the high direct costs associated with increased utilization of services and the indirect costs caused by school and work absenteeism.

This project compares laboratory-confirmed cases of influenza A and B in terms of their epidemiology and clinical outcomes, and describes the comparative epidemiology of laboratory-confirmed influenza A and B cases in Manitoba over the period from 1990 to 2011.

This analysis compares, by influenza type, the overall and cause-specific incidence rates of physician encounters, hospitalization and death following the diagnosis of a laboratory-confirmed influenza. It also describes multivariate models to assess the effects of influenza type on clinical outcomes (e.g., hospitalization) while accounting for confounding by demographic, socioeconomic, geographic and clinical (e.g., co-morbidity, immune status) characteristics.

The study also assesses secular and seasonal trends in the incidence rates of influenza A and B cases in Manitoba during the period of 1990-2011, excluding the 2009 H1N1 pandemic period (April 2009-April 2010) and assesses whether these rates vary for different subsets of the population defined by demographic (e.g., age group, gender), socioeconomic, geographic (neighborhood of residence) and clinical (e.g., vaccination, presence of chronic conditions, immune status) characteristics.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any person who normally resides in Manitoba and who has been continuously covered during the study period will be eligible for inclusion in the study.

Criteria

Inclusion Criteria:

  • Any person who normally resides in Manitoba and who has been continuously covered during the study period will be eligible for inclusion in the study.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683630

Contacts
Contact: Salah Mahmud, MD, PhD (204)-940-3611 salah.mahmud@gmail.com
Contact: George J Wurtak, MEd 204-943-0038 gwurtak@icid.com

Locations
Canada, Manitoba
International Centre for Infectious Diseases Not yet recruiting
Winnipeg, Manitoba, Canada, R3B 3P5
Principal Investigator: Salah Mahmud, MD, PhD         
Sponsors and Collaborators
International Centre for Infectious Diseases, Canada
Investigators
Principal Investigator: Salah Mahmud, MD, PhD Assistant Professor, University of Manitoba
  More Information

No publications provided

Responsible Party: International Centre for Infectious Diseases, Canada
ClinicalTrials.gov Identifier: NCT01683630     History of Changes
Other Study ID Numbers: ICID-2012-FLU-A,B-02
Study First Received: August 31, 2012
Last Updated: September 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by International Centre for Infectious Diseases, Canada:
Influenza
Influenza type A
Influenza type B
hospitalization
Manitoba
Canada

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014